non-inferiority study to compare the efficacy and safety of mylan's insulin glargine with lantus® in type 2 diabetes mellitus patients (instride 2)

Conditions: Type 2 Diabetes

Summary: to test whether mylan's insulin glargine once daily is non-inferior to lantus® once daily (both administered in combination with other anti-diabetic drugs) based on the change in hba1c from baseline to 24 weeks

this trial is a multi-center, open-label, randomized, parallel group trial in patients with t2dm comparing the efficacy and safety of mylan's insulin glargine with that of lantus®. patients with an established diagnosis of t2dm per ada 2014 criteria and who satisfy the selection criteria will be included in the trial. this will be followed by a 24-week randomized, comparative, parallel-assignment treatment period with mylan's insulin glargine or lantus® (in addition to other anti-diabetic drugs). after the treatment period, there will be a follow-up visit; 4 weeks after the patient has been put back on approved medications.

Eligibility criteria:
inclusion criteria: * patients with an established diagnosis of t2dm per ada 2014 criteria who also fulfill the following: * diagnosis established 1 year prior to screening * insulin-naïve or * on lantus® once daily at stable dose (±15% variation in dose) for at least 3 months prior to screening * body mass index (bmi) of 18.50 to 40.00 kg/m2 at screening (both values inclusive). * stable weight, with no more than 5 kg gain or loss, in the 3 months prior to screening; this information will be collected by patient interview during medical history. * hemoglobin ≥9.0 g/dl at screening * glycosylated hemoglobin (hba1c) of \<10.5% or between 7.5 to 10.5% for insulin naïve patients at screening. exclusion criteria: * history of hypersensitivity to any of the active or inactive ingredients of the insulin/insulin analog preparations used in the trial, or history of significant allergic drug reactions. * history of use of animal insulin within the last 3 years, any insulin other than lantus® within the last 3 months prior to screening, or use of biosimilar insulin glargine at any time prior to screening. * patients requiring basal-bolus insulin therapy or who in the opinion of the investigator require mealtime insulin in order to achieve glycemic control. * regular use of immune-modulator therapy in the 1 year prior to screening. * history of ≥2 episodes of severe hypoglycemia within the 6 months before screening or history of hypoglycemia unawareness (a sample questionnaire is provided in appendix i) as judged by the investigator. * history of ≥1 episode of hyperglycemic hyperosmolar coma or emergency room visits for uncontrolled diabetes leading to hospitalization within the 6 months prior to screening. * serological evidence of human immunodeficiency virus (hiv), hepatitis b (hbsag) or hepatitis c (hcvab) antibodies at screening. * history of drug or alcohol dependence or abuse during the 1 year prior to screening. * receipt of another investigational drug in the 3 months prior to screening (or as per local regulations), or if the screening visit is within 5 half-lives of another investigational drug (whichever is longer), or scheduled to receive another investigational drug during the current trial period.